Surgical clip applicator and apparatus including the same

ABSTRACT

Apparatus and methods for delivering a surgical clip to a patient during a minimally invasive surgical procedure are disclosed herein. An exemplary apparatus for isolating an atrial appendage of a patient includes a surgical clip that locks onto the atrial appendage of the patient, and a surgical clip applicator that releasably engages the surgical clip. The surgical clip can include a top portion and a bottom portion. The surgical clip applicator can include a first flexible flap and a second flexible flap. The first and second flexible flaps can be sufficiently rigid to prevent the surgical clip from falling off of the surgical clip applicator when the surgical clip is engaged to the surgical applicator and the surgical clip applicator is in a relaxed state, and sufficiently flexible to facilitate separation of the surgical clip from the surgical clip applicator when the surgical clip is locked onto the atrial appendage.

BACKGROUND OF THE INVENTIONS

1. Field of Inventions

The present inventions relate generally to devices for delivering andinstalling surgical clips.

2. Description of the Related Art

There are many instances where surgical clips are secured to tissuewithin a patient. One example of such a procedure is the treatment ofatrial fibrillation. Atrial fibrillation occurs when anatomicalobstacles in the heart disrupt the normally uniform propagation ofelectrical impulses in the atria. These anatomical obstacles (called“conduction blocks”) can cause the electrical impulse to degenerate intoseveral circular wavelets that circulate about the obstacles. Thewavelets (called “reentry circuits”) disrupt the normally uniformactivation of the left and right atria. Because of a loss ofatrioventricular synchrony, the people who suffer from atrialfibrillation also suffer the consequences of impaired hemodynamics andloss of cardiac efficiency. They are also at much greater risk ofstrokes and other thromboembolic complications because of loss ofeffective contraction and atrial stasis. With respect to strokes,thrombus can form in left atrial appendage, break off, and cause astroke. The risk of stroke for people with atrial fibrillation is aboutfive (5) times that of those who do not have atrial fibrillation.

Electrosurgical devices have been used in minimally invasive proceduresto form a set of three transmural epicardial encircling lesions thatcures paroxysmal atrial fibrillation in most patients. The epicardiallesion set that typically cures paroxysmal atrial fibrillation includesan encircling lesion around the right pulmonary vein pair, an encirclinglesion around the left pulmonary vein pair and an encircling lesionaround the left atrial appendage. Additional epicardial lesions arefrequently required for patients with persistent or permanent atrialfibrillation. A transmural “connecting” lesion that connects the lesionaround the right pulmonary vein pair to the lesion around the leftpulmonary vein pair may be required if these lesions do not overlap, anda transmural connecting lesion that connects the lesion around the leftpulmonary vein pair to the lesion around the left atrial appendage maybe required if these lesions do not overlap. Electrosurgical clamps maybe used to form the epicardial encircling lesions and electrosurgicalprobes may be used to form the epicardial connecting lesions. Exemplaryelectrosurgical clamps and surgical probes are disclosed in U.S. Pat.Nos. 6,142,994 6,610,055 and U.S. Patent Pub. Nos. 2003/0158547 A1 and2005/0119654 A1. In minimally invasive procedures, access to the heartis typically obtained via a thoracotomy and a relatively small (e.g.about 10 mm in diameter) access port.

There is, unfortunately, some likelihood that a patient's atrialfibrillation will not be cured by the above-described minimally invasiveepicardial procedure and such a patient will also continue suffer fromthe associated increase in the risk of stroke. In context of moreinvasive atrial fibrillation treatments, such as open heart surgicalmaze procedures, one method of reducing subsequent stroke risk inpatients is to isolate the interior of the atrial appendage from theleft atria. This eliminates the possibility of thrombus within theatrial appendage entering the blood stream. The isolation may beaccomplished by suturing the base of the atrial appendage closed, or byapplying a clip by hand to epicardial surface at the base of the atrialappendage.

The present inventor has determined that although the use of a clip is aconvenient way to isolate an atrial appendage, a need exist for a devicethat is capable of delivering a clip to a target tissue structure duringminimally invasive surgical procedures, where application by hand is notpossible.

SUMMARY OF SOME OF THE INVENTIONS

An apparatus in accordance with an invention herein includes a mountingportion configured to be removably secured to a clamp and an engagementportion configured to releasably engage at least a portion of a surgicalclip. Another apparatus in accordance with an invention herein includesa clamp and a clip applicator, associated with the clamp, including anengagement portion configured to releasably engage at least a portion ofa surgical clip. Still another apparatus in accordance with an inventionherein is a unitary structure configured to be removably secured to aclamp and to releasably engage at least a portion of a surgical clip.

Such apparatus provide a number of advantages. For example, the presentapparatus may be used to deliver a surgical clip to a target tissuestructure during minimally invasive surgical procedures. Morespecifically, after a surgical clip is removably secured to a clamp, theclamp may be moved to a closed (or substantially closed) orientation sothat the clip and clamp can be inserted into a patient through arelatively small access port. The clamp may then be used to positing thesurgical clip on the target tissue structure. Once the surgical clip isin place, the clamp may be separated from the clip and removed from thepatient.

The above described and many other features and attendant advantages ofthe present inventions will become apparent as the inventions becomebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of embodiments of the inventions will be made withreference to the accompanying drawings.

FIG. 1 is a perspective view of one example of a conventional clip thatmay be used in combination with a present invention.

FIG. 2 is a perspective view of a clip application apparatus inaccordance with one embodiment of a present invention.

FIG. 3 is a perspective view of a clamp.

FIG. 4 is a plan view of a portion of the clamp illustrated in FIG. 3.

FIG. 5 is a section view taken along line 5-5 in FIG. 4.

FIG. 6 is a plan view of a portion of a clip applicator in accordancewith one embodiment of a present invention.

FIG. 7 is a side view of the clip applicator illustrated in FIG. 6.

FIG. 8 is a section view taken along line 8-8 in FIG. 7.

FIG. 9 is a section view taken along line 9-9 in FIG. 7.

FIG. 10 is a section view taken along line 10-10 in FIG. 7.

FIG. 11 is a side view showing a clip prior to being secured to a clipapplication apparatus in accordance with one embodiment of a presentinvention.

FIG. 12 is a section view taken along line 12-12 in FIG. 11.

FIG. 13 is a side view showing the clip being secured to the clipapplication apparatus in illustrated in FIG. 11.

FIG. 14 is a section view taken along line 14-14 in FIG. 13.

FIG. 15 is a side view showing the clip secured to the clip applicationapparatus in illustrated in FIG. 10.

FIG. 16 is a section view taken along line 16-16 in FIG. 15.

FIG. 17 is a side view showing the clip application apparatusillustrated in FIG. 11 compressing the clip.

FIG. 18 is a side, section view showing the clip application apparatusillustrated in FIG. 11 locking the clip on a tissue structure.

FIG. 19 is a section view showing the clip on a tissue structure afterthe clip application apparatus has been withdrawn.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

Although the present inventions are not limited to use with anyparticular surgical clips, one example of a conventional surgical clipthat may be inserted into a patient and secured to a tissue structure isillustrated in FIG. 1. The exemplary surgical clip 100 is a unitarystructure that includes a top portion 102 and a bottom portion 104 thatpivot relative to one another about a pre-bent hinge 106 that is biasedto the open orientation illustrated in FIG. 1. The surgical clip 100also includes a locking apparatus 108 and a plurality of tissueengagement devices 110. Once the surgical clip 100 is locked in place,the tissue engagement devices 110 will prevent the surgical clip frommoving by pressing into the tissue. Scar tissue will also form aroundthe tissue engagement devices 110, which further prevents movement. Inthe illustrated embodiment, the locking apparatus 108 includes a firstlocking member 112 with a pair of inwardly extending cam surfaces 114and a second locking member 116 with a pair of deflectable latches 118.A cutout 120 in the top portion 102 of the surgical clip 100 allows thelatches 118 to move relative to one another.

The exemplary surgical clip 100 illustrated in FIG. 1 may be secured toa tissue structure, either by hand during invasive surgical proceduresor through the use the present surgical clip application apparatus 10illustrated in FIG. 2 during minimally invasive procedures, as follows.After the surgical clip 100 is positioned about the target tissuestructure, force is applied to the top and bottom portions 102 and 104and, as the top and bottom portions approach the locked orientation(FIG. 19), the latches 118 engage the cam surfaces 114 and move towardone another. The latches 118 continue to move toward one another untilthey pass the cam surfaces 114, at which time they spring apart. Thesurgical clip 100 is then released and the biasing force of the hinge106 forces the now spread apart latches 118 against the underside of thecam surfaces 114, thereby preventing the surgical clip 100 fromreturning to the open position. The surgical clip 100 may also beunlocked, if necessary, by pushing the latches 118 toward one another sothat the biasing force of the hinge 106 can force the latches 118through the cam surfaces 116.

The exemplary surgical clip application apparatus 10 illustrated in FIG.2 includes a clamp 200 and a surgical clip applicator 300 carried by theclamp. As used herein, the term “clamp” includes, but is not limited to,clamps, forceps, hemostats, and any other surgical device that includesa pair of opposable clamp members, at least one of which is movablerelative to the other. In some instances, the clamp members areconnected to a scissors-like arrangement including a pair of handlesupporting arms that are pivotably connected to one another. The clampmembers are secured to one end of the arms and the handles are securedto the other end. Certain clamps that are particularly useful inminimally invasive procedures also include a pair of handles and a pairof clamp members. Here, however, the clamp members and handles are notmounted on the opposite ends of the same arm. Instead, the handles arecarried by one end of an elongate housing and the clamp members arecarried by the other. A suitable mechanical linkage located within thehousing causes the clamp members to move relative to one another inresponse to movement of the handles. The clamp members may be linear orhave a predefined curvature that is optimized for a particular surgicalprocedure or portion thereof. The clamp members may also be rigid ormalleable.

One example of a clamp is generally represented by reference numeral 200in FIGS. 2-5. Referring more specifically to FIGS. 3-5, the clamp 200includes a pair of rigid arms 202 and 204 that are pivotably connectedto one another by a pin (not shown). The proximal ends of the arms 202and 204 are respectively connected to a pair handle members 206 and 208,while the distal ends are respectively connected to a pair of clampmembers 210 and 212. The clamp members 210 and 212 may be rigid ormalleable and, if rigid, may be linear or have a pre-shaped bend (asshown). A locking device 214 locks the clamp in the closed orientation,and prevents the clamp members 210 and 212 from coming any closer to oneanother than is illustrated in FIG. 3. The clamp 200 is also configuredfor use with a pair of soft, deformable inserts (not shown) that may beremovably carried by the clamp members 210 and 212 and allow the clampto firmly grip a bodily structure without damaging the structure. Tothat end, the clamp members 210 and 212 each include a slot 216 (FIGS. 4and 5) that is provided with a sloped inlet area 218 and the insertsinclude mating structures that are removably friction fit within theslots. The present surgical clip applicators may be mounted on one ofthe clamp members in place of the insert and, typically, there will beno insert on the other clamp member.

Turning to FIGS. 6-10, the exemplary surgical clip applicator 300includes a mounting portion 302, which secures the surgical clipapplicator to the clamp 200, and an engagement portion 304, whichreleasably engages the surgical clip 100. The mounting portion 302includes a base member 306 and a connector 308 that is configured toremovably mate with the clamp slot 216 (FIGS. 4 and 5). The exemplaryconnector 308 has a relatively thin portion 310 and a relatively wideportion 312, which may consist of a plurality of spaced members (asshown) or an elongate unitary structure, in order to correspond to theshape of the slot 216. The mounting portion may be modified so thatsurgical clip applicators in accordance with the present inventions maybe used in conjunction with clamps that do not include a clamp memberslot. Here, the connector 308 may be eliminated and the base memberreconfigured such that it includes a longitudinally extending apertureinto which a clamp member may be inserted. The aperture and base membershould be sized and shaped such that the base member will be forced tostretch when the clamp member is inserted in order to create a tightinterference fit between the base member and clamp member.

The engagement portion 304 includes a bottom surface 314, flexible flaps316 and an end stop 318. The exemplary flaps 316, which extendlongitudinally, have an inverted L-shape and together define a slot 320,are positioned along the sides of the bottom surface 314 and are used toreleasably engage the surgical clip. The flaps 316 have a fixed end 317(FIG. 9), which is connected to the bottom surface 314, and a free end319. Although the present inventions are not limited to use with anyparticular surgical clip, the exemplary surgical clip applicator 300 isconfigured for use with the surgical clip 100 illustrated in FIG. 1. Tothat end, the distal end of the surgical clip applicator 300 includes anopen region 322 (i.e. a region without one or more of the flexible flaps316) for the first locking member 112, an open region 324 for the tissueengagement device 110 on the clip bottom portion 104, and an open region326 for the hinge 106.

One method of securing the exemplary surgical clip 100 to the exemplarysurgical clip applicator 300 on the surgical clip application apparatus10 is illustrated in FIGS. 11-16. Referring first to FIGS. 11 and 12,the surgical clip 100 is placed on the engagement portion bottom surface314 at the open region 324 while the surgical clip applicator 300 is ina relaxed state. The surgical clip 100, which is oriented such that thehinge 106 faces proximally, is then moved in the direction indicated byarrow A (i.e. along the longitudinal axis of the surgical clipapplicator 300). The surgical clip 100 causes the flexible clipapplicator flaps 316 to deflect in the manner illustrated in FIGS. 13and 14 as the surgical clip moves through the slot 320 in the directionindicated by arrow A. More specifically, the portions of the flaps 316that are adjacent to the clip hinge 106 will deflect when aligned withthe clip hinge and will return to the unstressed state after the cliphinge moves past them. The movement in the direction indicated by arrowA, and corresponding deflection of the portions of the flaps 316 thatare adjacent to the clip hinge 106, will continue until the surgicalclip 100 reaches the stored position illustrated in FIGS. 15 and 16. Theend stop 318 may, if necessary, be used to prevent the surgical clip 100from moving too far in the proximal direction. In the stored position,the clip bottom portion 104 is held within the slot 320, the firstlocking member 112 is aligned with the open region 322, the tissueengagement device 110 on the clip bottom portion 104 is aligned with theopen region 324, and the hinge 106 is aligned with the open region 326.The surgical clip 100 is, at this point, “releasably engaged” to theclamp member 210, i.e. the surgical clip is secured to the clamp member210 in such a manner that the surgical clip will remain secured to theclamp member 210 without assistance from (and in the absence of contactwith) the clamp member 212, yet can also be readily disengaged from theclamp member 210.

It should be noted that the exemplary surgical clip applicationapparatus 10 includes a single surgical clip applicator 300. As such,the clip top portion 102 is not directly secured to the surgical clipapplication apparatus 10. There may, however, be some instances where apair of surgical clip applicators 300 are used to secure a surgical clipto both of the clamp members 210 and 212 in the surgical clipapplication apparatus 10.

Once the surgical clip 100 is in the stored position, and is removablysecured to the surgical clip applicator 300, as well as to the clamp 200by way of the surgical clip applicator, the surgical clip may beinserted into the patient with the surgical clip application apparatus10. As illustrated for example in FIG. 17, the clamp members 210 and 212may be brought into close proximity to one another, although not soclose that they cause the clip locking members 112 and 116 on thesurgical clip 100 to engage one another, so that the distal portion ofthe surgical clip application apparatus 10 can be inserted with thesurgical clip into a patient by way of a thoracotomy and/or a relativelysmall access port (e.g. about 10 mm). Once inside the patient, the clampmembers 210 and 212 may be moved apart so that the surgical clip 100will return to its open state (or partially opened state) and bepositioned around the target tissue structure, e.g. around theepicardial base of the left atrial appendage LAA. Next, as illustratedin FIG. 18, the clamp members 210 and 212 may be used to compress thesurgical clip 100 around the base of left atrial appendage LAA until thelocking members 112 and 116 lock the surgical clip in place. Thesurgical clip application apparatus 10 may then be opened and movedproximally, while the surgical clip 100 remains secured to the leftatrial appendage LAA, which cause the flexible clip applicator flaps 316to deflect and release the surgical clip.

With respect to materials and dimensions, and although the presentsurgical clip applicators are not limited to any particular materialsand dimensions, surgical clip applicators in accordance with the presentinventions may be formed from any suitable flexible biocompatiblematerial. Exemplary materials include polyurethane silicone,polyurethane/silicone blends and Pebax blends with a Shore hardness ofabout 30D to 55D. Preferably, the flaps 316 will be extremely flexible,i.e. just rigid enough to prevent the surgical clip 100 from falling offof the surgical clip applicator 300, in order to facilitate separationof the surgical clip and surgical clip application apparatus 10 afterthe surgical clip has been locked onto the target tissue structure. Thesize of the surgical clip applicator 300 will, of course depend upon thesize of the surgical clip that it is intended to hold. In theillustrated embodiment, the surgical clip applicator is about 40 mm to55 mm long and about 7 mm to 10 mm wide at its widest point. The flaps316 are about 1 mm to 3 mm high (measured from the bottom surface 314)and extend inwardly from the outer edge about 0.5 mm to 1.5 mm. The slot320 is about 6 mm to 7 mm wide and about 0.5 mm to 1.5 mm high (measuredfrom the bottom surface 314 to the underside of the flap 316) at itswidest point, and about 4 mm to 5 mm wide and about 2 mm to 3 mm high(measured from the bottom surface 314 to the top of the flap 316) at itsnarrowest point.

Turning to manufacture, and although the present surgical clipapplicators are not limited to any particular manufacturing processes,surgical clip applicators in accordance with the present inventions maybe formed as unitary structures (i.e. one piece structures) with amolding process such as injection molding or casting. Alternatively, thesurgical clip applicators may be formed from multiple parts that areindividually molded or machined and then secured to one another.

In other exemplary surgical clip application apparatus, the clamp andsurgical clip applicator described above may be combined into anintegral unit that cannot be readily separated. For example, thesurgical clip applicator may be molded onto a clamp member. Such asurgical clip applicator would, for example, extend completely aroundthe clamp member and/or include portions that are molded into the clampmember slots.

Although the inventions disclosed herein have been described in terms ofthe preferred embodiments above, numerous modifications and/or additionsto the above-described preferred embodiments would be readily apparentto one skilled in the art. By way of example, but not limitation, theflexible flaps may, instead of being L-shaped, be curved or planar.Planar flexible flap would be oriented at an acute angle with respect tothe bottom surface 314. Single flap configurations are also possible. Itis intended that the scope of the present inventions extend to all suchmodifications and/or additions and that the scope of the presentinventions is limited solely by the claims set forth below.

I claim:
 1. An apparatus for isolating an atrial appendage of a patient,the apparatus comprising: a surgical clip that locks onto the atrialappendage of the patient, the surgical clip including a top portion anda bottom portion; and a surgical clip applicator that releasably engagesthe surgical clip, the surgical clip applicator including bottom surfaceextending between a first flexible flap and a second flexible flap, thefirst flexible flap having a fixed end connected to the bottom surfaceand a free end, the second flexible flap having a fixed end connected tothe bottom surface and a free end, and the bottom surface comprising aflat surface extending the width of the clip and from the fixed end ofthe first flap to the fixed end of the second flap, wherein the firstand second flexible flaps are sufficiently rigid to prevent the surgicalclip from falling off of the surgical clip applicator when the bottomportion of the surgical clip is engaged to the surgical applicatorbetween the first and second flexible flaps and the surgical clipapplicator is in a relaxed state, wherein the free end of the firstflexible flap extends between the top and bottom portions of thesurgical clip when the surgical clip is engaged to the surgical clipapplicator, wherein the free end of the second flexible flaps extendsbetween the top and bottom portions of the surgical clip when thesurgical clip is engaged to the surgical clip applicator, and whereinthe first and second flexible flaps are flexible and configured todeflect to release the surgical clip from the surgical clip applicatorwhen the surgical clip is locked onto the atrial appendage.
 2. Theapparatus of claim 1, wherein the first and second flexible flapsdeflect during engagement of the surgical clip to the surgical clipapplicator.
 3. The apparatus of claim 1, wherein the first and secondflexible flaps comprise a flexible biocompatible material.
 4. Theapparatus of claim 1, wherein the first and second flexible flapscomprise a polyurethane silicone material.
 5. The apparatus of claim 1,wherein the first and second flexible flaps comprise apolyurethane/silicone blend material.
 6. The apparatus of claim 1,wherein the first and second flexible flaps comprise a Pebax blendmaterial.
 7. The apparatus of claim 1, wherein the first and secondflexible flaps comprise a material having a Shore hardness within arange from about 30D to 55D.
 8. The apparatus of claim 1, wherein thebottom surface of the surgical clip applicator together with the firstand second flexible flaps defines a slot that receives the bottomportion of the surgical clip.
 9. The apparatus of claim 1, wherein acentral section of the clip bottom portion contacts the bottom surfaceof the applicator when the surgical clip is engaged to the surgical clipapplicator.
 10. The apparatus of claim 1, wherein the apparatus providesa continuous interface between the bottom surface of the applicator andthe bottom portion of the clip, the continuous interface extendingbetween the fixed ends of the first and second flexible flaps, when thesurgical clip is engaged to the surgical clip applicator.
 11. Theapparatus of claim 1, wherein the first and second flexible flaps assumea closed position in the absence of any external force, the closedposition preventing the surgical clip from falling off of the surgicalclip applicator when the bottom portion of the surgical clip is engagedto the surgical applicator between the first and second flexible flaps.